Combination Products Regulation, Policy & Best Practices

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9:00 a.m. – 9:15 a.m.

Welcoming Remarks

Quynh Hoang, Consultant, King & Spalding LLP
David Fox, Partner, Hogan Lovells LLP

9:15 a.m. – 9:45 a.m.

Keynote Address: Combination Products — Perspective of the Combination Products Coalition

Bradley Merrill Thompson, Member, Epstein Becker & Green P.C.

9:45 a.m. – 11:00 a.m.

Combination Products Determination and Review Processes:  Impact of 21st Century Cures Act and Recent FDA Initiatives

Panelists:

Kirsten Paulson, Senior Director, Global CMC-Medical Device, Pfizer
Suzanne O’Shea, Director, Navigant Consulting
Heidi Gertner, Partner, Hogan Lovells

Moderator: David Fox, Partner, Hogan Lovells

11:15 a.m. – 12:15 p.m.

Postmarket Adverse Event Reporting and cGMP: What You Absolutely Need to Know

Panelists:

Khaudeja Bano, MD, Senior Medical Director, Abbott
Beverly Lorell, Senior Medical & Policy Advisor, King & Spalding LLP
Katlin McKelvie Backfield, Attorney at Law, Backfield PLLC

Moderator: Steve Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding LLP

1:15 p.m. – 2:15 p.m.

Promotion and Advertising of Combination Products: Key Postmarket Considerations

Panelists:

Glenn Byrd, Senior Director, Promotional Regulatory Affairs, AstraZeneca
Suzanne O’Shea, Director, Navigent Consulting

Moderator: Lisa Dwyer, Partner, King & Spalding, LLP

2:15 p.m. – 3:15 p.m.

Human Factors Study of a Generic Combination Product with a Device Delivery Constituent Part: When Is It Needed and How to Conduct One

Panelists:

Tor Alden, President, HS Design
Kirsten Paulson, Senior Director, Global CMC-Medical Device, Pfizer
Dick Horst, President, UserWorks, Inc.

Moderator: David Fox, Partner, Hogan Lovells

3:30 p.m. – 4:30 p.m.

Planning to Submit 510(k), De Novo or PMA with Drug Constituent Part? Know Your 21st Century Cures Act Requirements

Panelists:

Elaine Tseng, Partner, King & Spalding LLP
Janine Morris, Vice President & Senior Research Fellow, Global Regulatory Affairs—Devices, Eli Lilly and Company
Sugato De, Consultant, Parexel International

Moderator: Quynh Hoang, Senior Regulatory Consultant, King & Spalding LLP